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Cochlear Implant With Dexamethasone Eluting Electrode Array

Primary Purpose

Sensorineural Hearing Loss, Bilateral Hearing Loss

Status
Active
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
CI632D
CI632
Sponsored by
Cochlear
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Sensorineural Hearing Loss focused on measuring Cochlear Implant, Dexamethasone, Bilateral Hearing Loss, Sensorineural Hearing Loss

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Post-lingual, bilateral, moderate (≥ 40 dB HL) to profound sensorineural hearing loss at 250, 500and 1000 Hz and profound high-frequency hearing loss, defined by a pure-tone average (PTA) threshold, 2000 through 8000 Hz, ≥ 90 dB HL.
  • 18 years or older at time of consent.

Exclusion Criteria:

  • Abnormal cochlear and middle ear anatomy
  • History with cochlear implant surgery
  • Allergy to dexamethasone
  • Women who are pregnant or plan to become pregnant
  • Unable/unwilling to comply to study requirements

Sites / Locations

  • University of California Los Angeles(UCLA), Medical center
  • Rocky Mountain Ear Centre
  • University of Iowa
  • University of Michigan Health System
  • Michigan Ear Institute
  • Mayo Clinic Rochester Foundation
  • Washington University School of medicine
  • New York Eye & Ear infirmary of Mt. Sinai
  • NYU Langone Medical Center
  • University Hospitals Cleveland Medical center
  • The Ohio State University Eye and Ear Institute at Wexner Medical Center
  • Hearts for Hearing
  • Vanderbilt University Medical Center
  • University of Utah Hospital and Clinics
  • University of Virginia Medical Center
  • Fiona Stanley Hospital
  • Westmead Hospital
  • Royal Prince Alfred Hospital
  • Royal Victorian Eye and Ear Hospital
  • Gilles Hospital
  • St. George Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

CI632D Investigational Medical Device (IMD)

CI632 Comparator Device

Arm Description

Outcomes

Primary Outcome Measures

Comparison of Monopolar (MP1+2) impedance measurement (kOhms) between randomisation groups measured through Custom Sound software during clinical visits.
Change in speech perception performance (pre-recorded CNC words in quiet in sound booth testing) compared to pre-operative baseline measured during clinical visits.

Secondary Outcome Measures

Comparison of rate and type of device related adverse events between randomisation groups.
Comparison of speech perception performance (pre-recorded CNC words in quiet and AzBio sentences in quiet in sound booth testing) between randomisation groups measured during clinical visit.

Full Information

First Posted
January 31, 2021
Last Updated
September 8, 2023
Sponsor
Cochlear
Collaborators
NAMSA, Avania, Vanderbilt University
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1. Study Identification

Unique Protocol Identification Number
NCT04750642
Brief Title
Cochlear Implant With Dexamethasone Eluting Electrode Array
Official Title
Cochlear Implant With Dexamethasone Eluting Electrode Array (The CI-DEX Study): Pivotal Study
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
October 4, 2021 (Actual)
Primary Completion Date
February 28, 2024 (Anticipated)
Study Completion Date
February 28, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Cochlear
Collaborators
NAMSA, Avania, Vanderbilt University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Device Product Not Approved or Cleared by U.S. FDA
Yes
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
An evaluation of Cochlear's cochlear implant electrode array which passively elutes dexamethasone for a defined period of time to help reduce inflammatory responses.
Detailed Description
The primary objectives of the pivotal evaluation is to show the efficacy of the dexamethasone eluting electrode through reduction in electrode impedances as compared to a standard electrode and the improvement of speech recognition from preoperative baseline. The secondary objectives are to assess the benefit-risk balance of a dexamethasone eluting electrode as similar to a standard electrode by comparison of adverse events and speech outcomes.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sensorineural Hearing Loss, Bilateral Hearing Loss
Keywords
Cochlear Implant, Dexamethasone, Bilateral Hearing Loss, Sensorineural Hearing Loss

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare Provider
Allocation
Randomized
Enrollment
120 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
CI632D Investigational Medical Device (IMD)
Arm Type
Experimental
Arm Title
CI632 Comparator Device
Arm Type
Placebo Comparator
Intervention Type
Device
Intervention Name(s)
CI632D
Intervention Description
CI632 cochlear implant with Slim Modiolar electrode including dexamethasone in the electrode within wells (CI632D)
Intervention Type
Device
Intervention Name(s)
CI632
Intervention Description
CI632 cochlear implant with Slim Modiolar electrode with market approval and does not include dexamethasone
Primary Outcome Measure Information:
Title
Comparison of Monopolar (MP1+2) impedance measurement (kOhms) between randomisation groups measured through Custom Sound software during clinical visits.
Time Frame
Six months
Title
Change in speech perception performance (pre-recorded CNC words in quiet in sound booth testing) compared to pre-operative baseline measured during clinical visits.
Time Frame
Six months
Secondary Outcome Measure Information:
Title
Comparison of rate and type of device related adverse events between randomisation groups.
Time Frame
Six months and twelve months
Title
Comparison of speech perception performance (pre-recorded CNC words in quiet and AzBio sentences in quiet in sound booth testing) between randomisation groups measured during clinical visit.
Time Frame
Six months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Post-lingual, bilateral, moderate (≥ 40 dB HL) to profound sensorineural hearing loss at 250, 500and 1000 Hz and profound high-frequency hearing loss, defined by a pure-tone average (PTA) threshold, 2000 through 8000 Hz, ≥ 90 dB HL. 18 years or older at time of consent. Exclusion Criteria: Abnormal cochlear and middle ear anatomy History with cochlear implant surgery Allergy to dexamethasone Women who are pregnant or plan to become pregnant Unable/unwilling to comply to study requirements
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Aaron Parkinson
Organizational Affiliation
Cochlear
Official's Role
Study Director
Facility Information:
Facility Name
University of California Los Angeles(UCLA), Medical center
City
Los Angeles
State/Province
California
ZIP/Postal Code
90095
Country
United States
Facility Name
Rocky Mountain Ear Centre
City
Englewood
State/Province
Colorado
ZIP/Postal Code
80113
Country
United States
Facility Name
University of Iowa
City
Iowa City
State/Province
Iowa
ZIP/Postal Code
52242
Country
United States
Facility Name
University of Michigan Health System
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48109
Country
United States
Facility Name
Michigan Ear Institute
City
Novi
State/Province
Michigan
ZIP/Postal Code
48377
Country
United States
Facility Name
Mayo Clinic Rochester Foundation
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55905
Country
United States
Facility Name
Washington University School of medicine
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States
Facility Name
New York Eye & Ear infirmary of Mt. Sinai
City
New York
State/Province
New York
ZIP/Postal Code
10010
Country
United States
Facility Name
NYU Langone Medical Center
City
New York
State/Province
New York
ZIP/Postal Code
10017
Country
United States
Facility Name
University Hospitals Cleveland Medical center
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44106
Country
United States
Facility Name
The Ohio State University Eye and Ear Institute at Wexner Medical Center
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43212
Country
United States
Facility Name
Hearts for Hearing
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73120
Country
United States
Facility Name
Vanderbilt University Medical Center
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37232
Country
United States
Facility Name
University of Utah Hospital and Clinics
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84132
Country
United States
Facility Name
University of Virginia Medical Center
City
Charlottesville
State/Province
Virginia
ZIP/Postal Code
22903
Country
United States
Facility Name
Fiona Stanley Hospital
City
Murdoch
State/Province
New South Wales
ZIP/Postal Code
6150
Country
Australia
Facility Name
Westmead Hospital
City
Sydney
State/Province
New South Wales
ZIP/Postal Code
2145
Country
Australia
Facility Name
Royal Prince Alfred Hospital
City
Sydney
State/Province
New South Wales
ZIP/Postal Code
6150
Country
Australia
Facility Name
Royal Victorian Eye and Ear Hospital
City
East Melbourne
State/Province
Victoria
ZIP/Postal Code
3002
Country
Australia
Facility Name
Gilles Hospital
City
Auckland
ZIP/Postal Code
1010
Country
New Zealand
Facility Name
St. George Hospital
City
Christchurch
ZIP/Postal Code
8014
Country
New Zealand

12. IPD Sharing Statement

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Cochlear Implant With Dexamethasone Eluting Electrode Array

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